safety and tolerability of the treatment with Transplant-Acceptance Inducing Cells (TAIC) in terms of rejection episodes and Adverse Events (AEs)

Estimated Enrollment:

10

Study Start Date:

March 2005

Estimated Study Completion Date:

May 2006

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria

Patients must meet all the following inclusion criteria to be considered for admission to the trial:

Male or female adult patients aged between 18 and 64 years (inclusive). A female of childbearing potential may be enrolled provided she:

has a negative pregnancy test at Screening and

is routinely using adequate contraception prior to and during the study and

agrees not to attempt to become pregnant during the study and

is not lactating A female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilised.

Patients receiving a first renal transplant.

Patients who fulfil the criteria to receive an allogenic renal transplant (according to the Eurotransplant (ET) manual on organ allocation and the Bundesärztekammer allocation criteria) and who are listed on a waiting list.

Patients who, after the nature of the study and the disclosure of their data has been explained to them, have freely given Informed Consent in writing.

In vitro demonstration of the suppressive effect of the donor TAIC for the donor-recipient pair.

Exclusion Criteria (for the recipient)

Exclusion Criteria (for the recipient):

Patients presenting any of the following exclusion criteria must not be included in the trial:

Patients who have received a renal transplant.

Patients who have an active infection at the time of entry into the study (Screening).

Recipient and donor pairs who show the following incompatible EBV or CMV constellation: the donor is EBV or CMV positive and the recipient is EBV or CMV negative.

Patients and/or donors who have positive evidence of HIV or have active virus hepatitis B and C.

Patients with a history of alcohol and/or drug abuse or sepsis.

Patients who are pregnant women or nursing mothers.

Known hypersensitivity or contraindication to one of the immunosuppressives administered during the course of the study: ATG, tacrolimus, or steroids (prednisolone).

Missing immunosuppressive effect of the donor TAIC for the donor-recipient pair in vitro test.

Patients who are simultaneously participating or plan to participate in any other clinical study.

Psychiatric or emotional problems or lack of knowledge of the German language which would invalidate the giving of Informed Consent or limit the ability of the subject to comply with study requirements.

Unwillingness or inability to provide Informed Consent or to participate satisfactorily for the entire trial period

Patients with corresponding donors presenting any one of the exclusion criteria documented in the Eurotransplant guidelines ( ) must not be included in the trial.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223067